Device, method and system for measuring and recording reactant arrays

Abstract

The devices, systems, and methods include a system for analyzing a reactant array. The system may include a cartridge containing the reactant array and a device for analyzing the reactant array when the cartridge is received by or within the device. The cartridge may include a compartment for receiving a specimen in fluid communication with the reactant array and an opening configured to receive a sample portion of the specimen. The system may include a specimen having a sample portion configured to be disposed within the compartment and a non-sample portion extending outward from the compartment.

Description

[Technical Field]

[0001] The present disclosure relates to sensing and analytical tools, etc. More particularly, the present disclosure relates to devices and systems for sensing and analyzing chemicals, and methods for making and using such devices. [Background technology]

[0002] A wide variety of devices have been developed for sample collection, storage, sensing, and analysis. These devices can be manufactured by any one of a variety of different manufacturing methods and used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. Summary of the Invention [Problem to be solved by the invention]

[0003] The present disclosure provides design, material, manufacturing methods, and use alternatives for sensing and analysis devices. It should be noted that collection, storage, sensing, and analysis techniques and systems are known, but there is a need for improvements to these techniques and systems. [Means for solving the problem]

[0004] An exemplary cartridge for use with a device for analyzing a colorimetric sensor array may include a colorimetric sensor array, a housing at least partially enclosing the colorimetric sensor array and which may define a compartment for receiving a sample, and an access opening extending from the exterior of the housing into the compartment for receiving the sample.

[0005] Alternatively or additionally to any of the embodiments in this section, the housing may include a lid, the lid being adjustable between an open position defining an access opening and a closed position blocking the access opening.

[0006] Alternatively or additionally to any of the embodiments in this section, the access opening may be a through-hole extending from the exterior surface of the housing to the compartment for receiving the specimen.

[0007] Alternatively or additionally to any of the embodiments in this section, the through-hole may be configured to receive a specimen comprising a swab. Alternatively or additionally to any of the embodiments in this section, the cartridge may further include a locking feature configured to prevent removal of the specimen from the housing.

[0008] In another example, a system for analyzing a reactant array may include a cartridge including a reactant array, a compartment for receiving a specimen in fluid communication with the reactant array, and an access opening configured to receive a sample portion of the specimen, and a device for analyzing the reactant array when the cartridge is received within the device.

[0009] Alternatively or additionally to any of the embodiments in this section, the cartridge may include a housing at least partially enclosing the reactant array, the housing defining a compartment for receiving the sample and an access opening through which the sample is inserted into the compartment.

[0010] Alternatively or additionally to any of the embodiments in this section, the housing comprises first and second components adjustable relative to one another between an open position defining an access opening and a closed position blocking the access opening.

[0011] Alternatively or additionally to any of the embodiments in this section, the housing is formed from a single housing component. Alternatively or additionally to any of the embodiments in this section, the cartridge may include a lock having a locked position to prevent removal of specimen from the cartridge.

[0012] Alternatively or additionally to any of the embodiments in this section, the lock may be automatically adjusted from an unlocked position to a locked position in response to the insertion of a specimen into the cartridge. Alternatively or additionally to any of the embodiments in this section, the device may be configured to automatically detect the insertion of a cartridge into the device.

[0013] Alternatively or additionally to any of the embodiments in this section, the device may be configured to automatically detect the insertion of a specimen into the cartridge. Alternatively or additionally to any of the embodiments in this section, the device may be configured to collect light from the reactant array in response to a cartridge being placed within the device.

[0014] Alternatively or additionally to any of the embodiments in this section, the system may further include a specimen, which may include a sample portion for placement within the compartment and a non-sample portion extending outward from the compartment.

[0015] Alternatively or additionally to any of the embodiments in this section, the cartridge may be configured to separate a portion of the non-sample portion from the sample portion. In another example, a cartridge for use with a device for analyzing a reactant array may include a reactant array, a housing at least partially enclosing the reactant array and which may define a compartment for receiving a sample, and an access opening extending from the exterior of the housing into the compartment for receiving the sample.

[0016] Alternatively or additionally to any of the embodiments in this section, the housing may include first and second components adjustable relative to one another between an open position that defines an access opening and a closed position that blocks the access opening.

[0017] Alternatively or additionally to any of the embodiments in this section, the access opening may be a through-hole extending from the exterior surface of the housing to the compartment for receiving the specimen.

[0018] Alternatively or additionally to any of the embodiments in this section, the through-hole may be configured to receive a specimen, and the specimen comprises a swab. Alternatively or additionally to any of the embodiments in this section, the cartridge may further include a lock configured to prevent removal of the specimen from the housing.

[0019] Alternatively or additionally to any of the embodiments in this section, the lock may be configured to adjust from an unlocked position to a locked position in response to receiving a specimen within the compartment.

[0020] Alternatively or additionally to any of the embodiments in this section, the cartridge may further include a blade configured to sever a specimen received in the compartment.

[0021] Alternatively or additionally to any of the embodiments in this section, the cartridge may be configured to fluidly isolate the compartments and reactant array from fluids external to the housing.

[0022] In another example, a method of analyzing a reactant array may include inserting a specimen into a cartridge, the specimen including a sample portion, a compartment in fluid communication with the reactant array, the sample portion being disposed in the compartment of the cartridge; inserting the cartridge into a device, the cartridge including the compartment and the reactant array, the device configured to analyze the reactant array by collecting light through the cartridge; and collecting light from the reactant array using the device after the cartridge is inserted into the device.

[0023] Alternatively or additionally to any of the embodiments in this section, the method may further include locking the specimen within the cartridge in response to receiving the specimen within the cartridge.

[0024] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation in the present disclosure. The following figures and detailed description more particularly exemplify these embodiments.

[0025] The present disclosure may be more fully understood from the following detailed description considered in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0026] [Figure 1] FIG. 1 is a schematic diagram of an exemplary sensing system. [Figure 2] FIG. 1 is a schematic diagram of an exemplary computing system. [Figure 3] FIG. 1 is a schematic diagram of an exemplary sensing system in a user's hand. [Figure 4] 1 is a schematic perspective view of an exemplary cartridge. [Figure 5] FIG. 5 is a schematic perspective view of the exemplary cartridge of FIG. 4 with a specimen partially inserted. [Figure 6] 5 is a schematic perspective view of the exemplary cartridge of FIG. 4, with the exemplary cartridge in a closed position and with a specimen partially inserted. [Figure 7] FIG. 1 is a schematic perspective view of an exemplary cartridge, with the exemplary cartridge in an open position. [Figure 8] FIG. 8 is a schematic perspective view of the exemplary cartridge of FIG. 7 with a specimen inserted therein. [Figure 9] FIG. 8 is a schematic perspective view of the exemplary cartridge of FIG. 7, with the cartridge in a closed position and a specimen inserted. [Figure 10] 1 is a schematic perspective view of an exemplary cartridge in an open position with a specimen inserted therein. FIG. [Figure 11] 11 is a schematic perspective view of the exemplary cartridge of FIG. 10, with the exemplary cartridge in a closed position and with a specimen inserted. [Figure 12]1 is a schematic perspective view of an exemplary cartridge in an open position with a specimen inserted therein. FIG. [Figure 13] 13 is a schematic cross-sectional view of the exemplary cartridge of FIG. 12 with a specimen inserted therein. [Figure 14] FIG. 1 is a schematic diagram of an exemplary technique for analyzing a reactant array. DETAILED DESCRIPTION OF THE INVENTION

[0027] While the present disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the invention is not intended to be limited to the particular embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0028] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. The term "fluid" includes both liquids and gases.

[0029] All numerical values ​​are assumed herein to be modified by the term "about," whether expressly stated or not. The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure.

[0030] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0031] It should be noted that references herein to "one configuration," "several configurations," "other configurations," etc. indicate that the described configurations may include one or more particular features, structures, and / or characteristics. However, such descriptions do not necessarily imply that all embodiments include the particular feature, structure, and / or characteristic. Additionally, if a particular feature, structure, and / or characteristic is described in connection with one configuration, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other configurations, whether or not explicitly described, unless expressly stated otherwise.

[0032] The following detailed description should be read with reference to the drawings, in which like structures in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the present disclosure. Additionally, it should be noted that in any given drawing, some features may not be shown or may be shown in schematic form for clarity and / or simplicity. Additional details regarding some components and / or method steps may be shown in more detail in other drawings. The devices and / or methods disclosed herein may provide several desirable features and advantages, as described in more detail below.

[0033] Fluids having concentrations of volatile compounds (e.g., volatile organic compounds (VOCs)) and / or gases, which may or may not be harmful, may be sensed, analyzed, and / or monitored. Sensing, analyzing, and / or monitoring of fluids using analytes (e.g., non-volatile or volatile compounds, gases, liquids, and / or other fluids) may utilize absorption and / or reflectance measurements of reactants exposed to such fluids for any purpose, including, but not limited to, diagnostic hazard warnings, manufacturing process or quality control, record keeping, archival purposes, product development, product-to-consumer matching, etc.

[0034] In some cases, VOCs and / or gases are present in ambient fluids (e.g., ambient air, etc.) and can be sensed, analyzed, and / or monitored using reactive agents for real-time alerts, to treat subjects, or to collect and / or archive data for health records, regulatory compliance records, etc. Additionally, a subject (e.g., VOCs and / or gases exhaled or emitted, exhaled, effused, emitted, and / or secreted from a subject (e.g., a human, a non-human animal, food, produce, meat, a pathogen, bacteria (e.g., good and / or bad bacteria), plants, a wound, an ulcer, a surgical site, a subject's skin, a subject's mouth, a subject's nasal cavity, a subject's sinuses, a subject's rectal area, a subject's vaginal area, a subject's genital area, a subject's ear canal, a subject's pores, etc.) may be sensed, analyzed, and / or monitored to assess harmful, dangerous, or illegal substances in or at the subject or target site, the subject's lung condition, a blood disorder condition, an infection condition, a condition related to a disease or biological condition, a condition related to overall body health, a condition related to the flavor of food, a condition related to a perfume or odor, and / or other suitable condition.

[0035] Systems discussed herein for sensing, analyzing, and / or monitoring fluids (e.g., for analytes of interest) may be configured to accurately detect and record a reactive array (e.g., a colorimetric sensor array (CSA) reactive array, or other suitable reactive array) upon exposure to the fluid. The systems may employ techniques to noninvasively detect one or more analytes of interest (e.g., one or more pathogens responsible for certain human skin infections, including, but not limited to, skin infections, urinary tract infections (UTIs), vaginitis, wound infections, ulcers, etc., and / or other suitable analytes) from the fluid using the CSA to enable early detection and implementation of protocols to address one or more conditions associated with any sensed analytes of interest. In one example, improved classification of one or more analytes using the systems described herein may enable detection and identification of the causative pathogen at a very early stage of a dangerous skin infection, which may result in a high level of protection and probability of a favorable outcome for the subject.

[0036] An analytical system (e.g., a CSA analytical system) can include a housing or cartridge containing a reactant array (e.g., a CSA having a reactant array) and a device for reading or analyzing the CSA in the cartridge before, during, and / or after the reactant array is exposed to a fluid. The device (e.g., a reading device) for analyzing the reactant array can be or include a spectrometer or other suitable image or light collector / sensor. In some cases, the device can be configured to be a handheld device. Furthermore, a device for analyzing a reactant array can be configured to be easy to use, minimize human error, reduce sample cross-contamination, and reduce human risk of exposure to analytes received in the device.

[0037] In operation, a housing cartridge containing a reactant array can be placed into a device (e.g., via an opening in the device) to analyze the reactant array before, during, and / or after exposure to a fluid for optimal image / reflectometry analysis of the reactant array. That is, analysis of the reactant array in the cartridge can include analyzing the reactant array before exposure to the fluid, during exposure to the fluid, and / or after exposure to the fluid is complete. Once analysis of the reactant array in the cartridge is complete, the cartridge can be removed from the device to analyze the reactant array and discarded. Making the cartridge disposable can prevent cross-contamination and erroneous analysis of the reactant array (e.g., due to previous fluid remaining in the tubing and re-flowing over the reactant array and undesirably into the human body, etc.).

[0038] A cartridge may be any suitable component that includes one or more reactant arrays (e.g., where the reactant arrays may be permanent or removable from the cartridge) and may be configured to expose the one or more reactant arrays to fluid from a target region or site. In one example, the cartridge may be a flow cell and may have an input port for accepting fluid (e.g., fluid from a target region or site) over and / or through the one or more reactant arrays and an output port for outputting fluid that has passed through and / or over the one or more reactant arrays. In an example, the accepted fluid may be pressurized via pressurized fluid (e.g., N2, etc.) from an external source and / or may be pressurized via a pump in communication with a fluid path between the input and output ports of the cartridge.

[0039] In additional or alternative configurations, the cartridge may be configured to receive a sample containing a specimen from a target area or site. In some cases, the cartridge may include a compartment configured to receive at least a portion of the specimen having the sample thereon and / or therein.

[0040] If the cartridge is configured to receive a specimen, the received specimen may be or include any suitable specimen substrate configured to collect or carry a sample or fluid from a subject. The specimen may be or include a specimen substrate having a sample from a target site. Exemplary suitable specimen substrates may include, but are not limited to, swabs, stick swabs (e.g., Q-tips), sponges, sample plates, test strips, needles, syringes, and the like.

[0041] The compartment of the cartridge configured to receive at least the specimen substrate may be accessed in any suitable manner. For example, the compartment may be accessed to receive the specimen via an access opening extending from the exterior of the housing into the compartment. Exemplary access openings include, but are not limited to, one or more openings extending through the housing that define or at least partially define the compartment (e.g., a through-hole extending from the exterior of the housing to the compartment), a lid (e.g., a clamshell configuration or other suitable lid configuration) configured to adjust (e.g., pivot) between an open position of the cartridge providing access to the compartment and a closed position of the cartridge sealing the compartment and / or blocking access to the compartment through the access opening, and / or other suitable configuration of the cartridge configured to receive and secure the specimen within the cartridge. For example, if the specimen includes a stick-attached swab as the specimen substrate, the cartridge may be configured to receive the stick-attached swab or other suitable specimen into the compartment via the through-hole such that the stick extends out of the through-hole opening of the cartridge.

[0042] Once a specimen is received within the cartridge, the cartridge may be configured to maintain the specimen within the compartment or to allow the specimen to be removed from the cartridge before, during, and / or after analysis of a sample of the specimen. In some cases, the compartment of the cartridge may be sealed upon receiving the specimen, but this is not required. After the specimen is received within the cartridge, sample or fluid on or within the cartridge may flow from the specimen and / or permeate one or more CSAs within the cartridge.

[0043] In some cases, the cartridge may include a locking mechanism configured to lock the specimen within the cartridge. In one example of a locking mechanism, the cartridge may include a locking mechanism configured to sever the specimen stick at the exterior surface of the opening or through-hole and then seal the opening. Alternatively or additionally, the locking mechanism configured to sever the specimen stick or other portion may be part of a lid configured to separate a specimen inserted into the cartridge into a sample portion that is secured within the cartridge compartment and a non-sample portion that is removed from the cartridge. Other suitable locking mechanisms include, but are not limited to, mechanisms that engage and prevent removal of the received specimen after placement of the specimen within the compartment, and / or other suitable locking mechanisms configured to prevent removal of the specimen from the housing and / or facilitate single-use of the cartridge (e.g., to prevent cross-contamination of samples).

[0044] If the cartridge includes a lid, the locking mechanism may be configured to lock the lid in a closed position after a specimen is received into the cartridge. In some cases, if the lid is configured to lock in a closed position after a specimen is received into the cartridge, the locking mechanism may permanently lock the lid in the closed position, and the permanent locking may be triggered by receiving a specimen into the cartridge and accomplished by closing the lid, although this is not required and other suitable permanent locking systems may be utilized.

[0045] For example, as discussed herein, a cartridge configured to receive a specimen, including a sample, from a target site, as opposed to a cartridge configured to receive a sample or fluid in other suitable manners (e.g., via a fluid pathway extending between input and output ports of the cartridge), may provide, among other advantages, reduced cross-contamination, reduced setup complexity by eliminating the need for tubing, reduced site preparation time, minimized fluid and / or sample analysis time, and increased concentration of sample and / or fluid collected from the target area or site (e.g., via the use of a specimen). Additionally, if a swab or other common sample collection device is used as the specimen substrate for collecting the sample from the target area or site, the clinician may be using a familiar collection device, which may allow for effective collection and maintenance of the sample on the specimen due to the use of known techniques common to clinical environments.

[0046] Returning to the drawings, Figure 1 shows a schematic diagram of an exemplary system 10 for analyzing a reactant array. System 10 may include, among other components, a cartridge 12 having a reactant array 18 and a reading device 14 configured to monitor and / or analyze the reactant array 18. In some configurations, system 10 may include a specimen 16 configured to collect a sample from a target area (e.g., a wound, pollen from a flower, an infection, breath exhaled from a subject, sweat glands, etc.) for analysis using cartridge 12 and / or reading device 14.

[0047] Cartridge 12 may have any suitable configuration and may include any suitable components configured to facilitate receiving sample 16, sensing analytes from sample 16, and interfacing with reading device 14. Exemplary components of cartridge 12 include, but are not limited to, one or more reactant arrays 18, one or more compartments 20, one or more locks 22, one or more sample detectors 24, and / or one or more other suitable components and / or configurations. Components that the cartridge 12 may include, but are not shown in FIG. 1 , include, but are not limited to, a housing, a window for viewing the reactant array 18, a blade for engaging the specimen 16, one or more gaskets or other features for hermetically sealing one or more compartments, one or more access openings extending between the compartments and the exterior of the housing, one or more valves configured to seal the access openings, one or more doors or lids, one or more pumps for pumping fluid from the location of the specimen 16 to the reactant array 18, one or more fluid paths or passageways, tubing, one or more diaphragms or membranes, one or more single-use components, and / or other suitable components.

[0048] 1 , cartridge 12 may include a housing that may be configured to at least partially enclose or house all or one or more of reactant array 18, compartments 20, lock 22, and sample detector 24. The housing may be a single component having one or more openings between one or more compartments 20 and the exterior of cartridge 12, and / or may be multiple components that define openings between one or more compartments 20 and the exterior of cartridge 12.

[0049] The housing may be formed in any suitable manner, in some examples, the housing may be formed by one or more molding techniques, injection molding techniques, welding techniques, ultrasonic welding techniques, three-dimensional (3D) printing techniques, and / or other suitable techniques.

[0050] The housing of cartridge 12 may be formed from any suitable material, including, but not limited to, polymer, metal, glass, and / or other suitable types of materials.

[0051] The housing of cartridge 12 may have any suitable shape and / or size configured to receive a sample and facilitate analysis of the array of reactants in cartridge 12 using reading device 14. For example, cartridge 12 may include a cubic shape, an elongated shape, a rectangular shape, an oval shape, a rounded shape, a circular shape, a spherical shape, and / or other suitable shapes.

[0052] The reactant array 18 may be any suitable array of one or more reactants (e.g., analyte-sensitive materials), and the reactants of the reactant array 18 may be formed from any suitable material. The cartridge 12 (e.g., the housing of the cartridge 12) may be configured to completely or at least partially contain or surround the reactant array 18 (e.g., a CSA including the reactant array 18). In some cases, the reactant array 18 may be part of or form a colorimetric sensor array (CSA), although other suitable configurations are contemplated. Additionally or alternatively, the reactant array 18 may be formed by applying the reactant material to all or at least a portion of the interior surface of the cartridge 12 (e.g., the surface of the compartments 20), and the applied reactant material may be in a continuous pattern, partitioned, segmented, perforated, and / or one or more other suitable designs or configurations.

[0053] The reactant materials of the reactant array 18 may be reversible (e.g., reusable), semi-reversible, or non-reversible (e.g., single-use). In some examples, the reactant materials may be optically responsive chemical materials (e.g., chemically responsive materials) that change color in response to the detection of one or more analytes (e.g., volatile compounds, gases, liquids, and / or other fluids) in a fluid to which the reactant is exposed, although other suitable materials are contemplated. Examples of suitable materials for the reactant include, but are not limited to, dyes from the following classes: Lewis acid / base dyes (e.g., metal-containing dyes), Bronsted acidic or basic dyes (e.g., pH indicators), dyes with large permanent dipoles (e.g., solvatochromic dyes), redox-responsive dyes (e.g., metal nanoparticle precursors), and / or other suitable types of dyes. One example of a reactant material may be a silver nanoparticle material. Other suitable materials for the reactant are contemplated, including printed dyes or reactant materials other than optically responsive chemical materials.

[0054] The reactants of the reactant array 18 may be applied to a substrate. If the reactant array 18 forms or is part of a CSA, the substrate may or may not be part of the CSA. Additionally or alternatively, the substrate may be the cartridge 12 (e.g., the cartridge housing and / or other suitable component of the cartridge) or a component configured to be received within the cartridge 12 (e.g., in one or more of the compartments 20).

[0055] The reactants of the reactant array 18 may be applied to the substrate in any suitable manner. In one example, the reactants may be applied to the substrate by printing the reactants (e.g., reactant material) onto the substrate. If printed, any suitable printing technique may be utilized, including, but not limited to, pin transfer, inkjet, silkscreen, and / or other suitable application techniques.

[0056] The reactive agents may be applied to the substrate randomly and / or to form one or more patterns. Exemplary configurations of reactive agents in a reactive agent array applied to a substrate include, but are not limited to, a grid pattern of rows and columns, concentric rings, color matching of the printed dye material with the color of the substrate material before the reactive agents interact with the analyte, a pattern that results in a distinguishable shape when the analyte-sensitive material reacts with a particular analyte, other suitable configurations, and / or combinations thereof.

[0057] One or more compartments 20 of cartridge 12 may be defined completely or at least partially by the housing of cartridge 12. One or more compartments 20 may be in fluid communication with one or more access openings that extend from outside cartridge 12 (e.g., the housing of cartridge 12) into one or more compartments 20. In some examples, the access openings may be configured to receive a specimen 16 for placement into one or more compartments 20.

[0058] The one or more compartments 20 may include any suitable configuration of compartments 20. For example, a compartment 20 may define a fluid pathway from the location of the sample 16 to the reactant array 18, may be a single compartment 20 that includes the reactant array 18 and is configured to receive the sample 16, may be or include multiple compartments that are fluidly coupled to allow fluid to pass between the location of the sample 16 and the location of the reactant array 18, and / or may have one or more other suitable configurations. Although not shown, the one or more compartments may be or include one or more tubes that define at least a portion of the fluid pathway from the location of the sample 16 to the reactant array 18.

[0059] Once the specimen 16 is received in or by the cartridge 12, the cartridge 12 may maintain the specimen 16 in or at the compartment 20 or may allow the specimen 16 to be removed from the cartridge 12 before, during, and / or after analysis of a sample (e.g., fluid from) on or of the specimen 16. In some configurations, the compartment 20 of the cartridge 12 may be sealed upon receiving the specimen 16, although other configurations are contemplated. After the specimen is received in the cartridge, fluid on or in the specimen may flow from the specimen 16 and / or permeate the reactant array 18 within the cartridge 12.

[0060] Lock 22 may have any suitable configuration. In some examples, lock 22 may be any suitable component configured to selectively block access to compartment 20 through an access opening. If the housing of cartridge 12 includes multiple components adjustable relative to one another between an open position defining an access opening and a closed position blocking access to compartment 20 through the access opening, the lock may be configured to secure the multiple components relative to one another (e.g., in the closed position and / or other suitable positions).

[0061] Lock 22 may be configured to secure specimen 16 relative to cartridge 12. In one example, cartridge 12 may include a blade or blade surface configured to cut the specimen into two subcomponents and then seal the access opening. Alternatively or additionally, lock 22, including a blade or blade surface configured to cut the specimen, may be part of a component of the housing of cartridge 12 configured to separate a specimen inserted into cartridge 12 into a sample portion that is secured within a compartment of cartridge 12 and a non-sample portion that is removed from the cartridge. In some examples, receipt of specimen 16 within the access opening may trigger lock 22 to close the access opening and / or engage the specimen, preventing removal of specimen 16. Other suitable features of the lock 22 include, but are not limited to, features that engage with the received specimen 16, features that prevent removal of the received specimen 16 after placement of the specimen 16 within the compartment 20, spring-loaded doors, automatic doors, bolts, latches, magnets, and / or other suitable features of the lock configured to prevent removal of the specimen 16 from the housing, facilitate single-use of the cartridge (e.g., to prevent cross-contamination of samples), and / or couple multiple components of the housing to each other and / or to the specimen 16.

[0062] In some instances, the lock 22 may be irreversible so that the specimen 16 cannot be removed from the cartridge 12 and so that the lock 22 facilitates ensuring that the specimen 16 and cartridge 12 are only used to test one sample. In other instances, the lock 22 may be reversible to allow the specimen 16 to be repositioned relative to the cartridge 12.

[0063] Any suitable type of lock 22 may be utilized. Exemplary suitable types of lock 22 include, but are not limited to, an automatically actuated lock, a manually actuated lock, a spring-loaded lock, a latch, a deadbolt, a friction fit lock, and / or other suitable types of lock configured to block an access opening and / or engage a sample to prevent removal and / or adjustment of the sample 16 relative to the cartridge 12.

[0064] Cartridge 12 may include one or more sample detectors 24. In some examples, sample detector 24 may be configured to detect when a sample is proximate to and / or received within cartridge 12 and may or may not be part of lock 22. In one example, sample detector 24 may be a pin or button or other component in communication with spring-loaded lock 22, which detects the sample and releases a spring in lock 22 to lock sample 16 within cartridge 12. Alternatively or additionally, sample detector 24 may be an electronic sensor or detector and / or other suitable type of detector that may provide an indication to reading device 14 that a sample has or has not been received within cartridge 12 (e.g., properly received or not received within cartridge 12).

[0065] In addition to or instead of the lock 22 and / or the sample detector 24, the cartridge 12 may include single-use components configured to prevent contamination due to cartridge reuse. In some cases, the single-use components may be mechanical, electrical, electromechanical, optical, chemical, magnetic, and / or other suitable types of single-use features, depending on whether they are used with a single-use or reusable reading device 14 to analyze the reactant array 18. In one example of a single-use component for the cartridge 12, an electronic single-use component may be embedded within the cartridge 12 and recognized by the reading device 14 as intact or broken, indicating whether the cartridge 12 is new or used. Exemplary electronic single-use components include, but are not limited to, memory devices, radio frequency identification (RFID) devices, fuses, and / or other suitable electronic single-use components. If a memory device is used as a single-use component of cartridge 12, the memory device may be accessed and modified by reading device 14 after cartridge 12 is inserted into reading device 14. If a fuse is used as a single-use component, the fuse may be destroyed (e.g., via excessive current or in other suitable manner) after reading device 14 analyzes reactant array 18, in which case reading device 14 may be configured to identify the destroyed fuse and prevent cartridge 12 having the destroyed fuse from being used in subsequent analyses. Additionally, the single-use component may be or include at least one visual indicator that can change state after use with reading device 14 and that can be captured by an image capture sequence of reading device 14, such that if reading device 14 determines from the indicator that cartridge 12 has been used, reading device 14 prevents use of cartridge 12.

[0066] In some cases, cartridge 12 may be reusable. For example, if reactant array 18 and / or other components of cartridge 12 have been used or may have become contaminated with received fluids, reactant array 18 and / or other used or contaminated components of cartridge 12 may be removed from cartridge 12, and the remaining components of cartridge 12 may be reused after cleaning, if necessary. In some cases, reactant array 18 includes reversible reactant materials, and reactant array 18 may be reused along with other components of cartridge 12.

[0067] The specimen 16 may be configured to collect a sample from a target area, where the sample is configured to exude a fluid. In some examples, the specimen 16 may include a sample portion 26 configured to contact the target area to collect the sample, which exudes a fluid. The specimen 16 may also include a non-sample portion along with the sample portion 26, where the non-sample portion may be manipulated by a user to place the specimen in the cartridge and / or to collect the sample. When the specimen 16 is placed in a compartment 20 of the cartridge 12, the sample portion 26 of the specimen 16 may be inserted into the compartment 20 and the non-sample portion may extend out of the compartment 20, although other suitable configurations are contemplated.

[0068] The specimen 16 can be any suitable type of specimen component configured to collect a sample from a target area. Exemplary suitable types of specimen 16 include, but are not limited to, a swab, a swab with a stick (e.g., a Q-tip), a container, a sponge, a sample plate, a test strip, a vessel, a needle, a stick, a syringe, and / or other suitable types of specimen configured to support a sample.

[0069] The reading device 14 may include other suitable components for reading and / or analyzing the reactant array 18. Exemplary suitable components of the reading device 14 include, but are not limited to, illumination components, light collection components, one or more light or image sensors 28, one or more cartridge detectors 30, one or more controllers 32, one or more light sources, one or more lens sets, one or more motors, one or more pumps, one or more buttons, one or more user interfaces, one or more displays, and / or other suitable components. In some examples, the reading device 14 may be a benchtop device or a handheld device. In some cases, the reading device 14 may be isolated from the specimen 16 sample and may be configured for reuse.

[0070] The reading device 14 may be powered using any suitable power source. Exemplary suitable power sources for powering the reading device 14 include, but are not limited to, battery power within the reading device 14, solar power at the reading device 14, wall or line power, and / or other suitable power sources. In some examples, to facilitate forming the reading device 14 in a handheld configuration, the reading device 14 may be powered by one or more batteries and / or by solar power.

[0071] The light sensor or image sensor 28 may be and / or include one or more light collectors of any suitable type. Exemplary suitable types of light collectors may include, but are not limited to, a light sensor, an image sensor, an n-dimensional sensory array (e.g., where “n” equals 1, 2, etc.), a linear 2D photodetector array image sensor, a photodetector array image sensor, a spectrometer, a refractometer, a charge-coupled device (CCD) image sensor, a complementary metal-oxide semiconductor (CMOS) image sensor, a contact image sensor (CIS), a color contact image sensor (CCIS), a camera, other suitable light collectors, and / or combinations of light collectors. In one example, a light collector may include or be a spectrometer configured to measure photons collected (e.g., reflected, transmitted, and / or otherwise received) from the reactant array. Utilizing a spectrometer can facilitate sensing wavelengths of light with high resolution in the nanometer range and can provide a continuous set of data across a range of wavelengths, thereby enabling analysis of data to identify components of the fluid to which the reactant array 18 is exposed with greater sensitivity than when other light collectors are used. In another example, the light collector may include a 2D pixel array image sensor configured to record multiple spatial interferograms in the pixel array direction of the interferograms representing the Fourier transform of the reactant array 18, which may provide sufficient sensitivity while being compact and cost-effective.

[0072] The reading device 14 may include one or more cartridge detectors 30. In some examples, the cartridge detector 30 may be configured to detect when the cartridge 12 is in proximity to and / or accepted by the reading device 14. In one example, the cartridge detector 30 may be a pin or button or other component that physically or mechanically engages the cartridge 12 when the cartridge 12 is inserted or placed within the reading device 14, and the pin or button or other component adjusts accordingly to provide a mechanical and / or electrical indication that the cartridge 12 has been accepted (e.g., a circuit is completed, etc.). Alternatively or additionally, the cartridge detector 30 may be an electronic sensor or detector and / or other suitable type of detector that may provide an indication to the reading device 14 that the cartridge 12 is in proximity to and / or accepted or not accepted within the reading device 14 (e.g., properly accepted or not accepted within the reading device 14). In some cases, an electronic sensor or detector may sense a signal (e.g., an RF signal) from cartridge 12, sense that cartridge 12 has interrupted the circuit of reading device 14, completed the circuit of reading device 14 and / or cartridge 12, and / or sense the presence of cartridge 12 in one or more other suitable ways.

[0073] In addition to or instead of cartridge detector 30, reading device 14 may include a single-use component. The single-use component of reading device 14 may include features configured to electrically, mechanically, or electrically and mechanically modify cartridge 12 to prevent cartridge 12 from being used more than once by reading device 14 (e.g., in more than one test by reading device 14). Examples of single-use components include, but are not limited to, a component configured to write to an RFID tag on cartridge 12, a component configured to mechanically modify cartridge 12 to prevent rebinding of cartridge 12 after it has been removed from reading device 14, a camera configured to read a code (e.g., a barcode, QR code, alphanumeric code, color code, etc.) on the surface of cartridge 12, or an RFID reader configured to read the code from the cartridge's RFID tag and add the code or other identifying material to a list of used cartridges in reading device 14 and / or in a memory in communication with reading device 14.

[0074] The cartridge detector 30 and / or other suitable detector of the reading device 14 may be configured to detect when the sample 16 is present in or on the cartridge 12. For example, the cartridge 12 may be inserted into the reading device 14 before the sample 16 is present in the cartridge 12, and the cartridge detector 30 may detect when the sample 16 is inserted into the cartridge 12 after the cartridge 12 has been inserted into the reading device 14. Upon sensing the cartridge 12 in the reading device 14 and the sample 16 in the cartridge 12, the reading device 14 may begin light or image collection from the reactant array 18 as part of a fluid analytical test of the sample on the sample 16 and / or begin requesting input from a user to perform one or more steps of the fluid analytical test.

[0075] The controller 32 of the reading device 14 may be configured to control the operation of the reading device 14 in response to receiving one or more control signals and / or usage inputs. The controller 32 may store the captured data on the reading device 14 and / or transmit the data to a remote storage component for storage, and the controller 32 may use the stored captured data to analyze the reactant array 18. Furthermore, the controller 32 may be implemented entirely on the reading device 14, partially on the reading device 14 and partially remotely, and / or entirely remotely (e.g., on a server or other suitable computing device, on the cartridge 12, on a user's mobile device, etc.).

[0076] The controller 32 of the reading device 14 may be coupled to one or more other electronic components of the system 10. For example, the controller 32 may be communicatively coupled to one or more of the illumination components (if included), the light or image sensor 28, the cartridge detector 30, the single-use components, and / or one or more other suitable components of the system 10, and / or to a remote component (e.g., a server, a mobile device, etc.) that may or may not be part of the system 10. In some examples, the controller 32 may be configured to receive instructions to initiate a fluid test (e.g., from a user via a user interface of the controller 32 or via a user interface in communication with the controller 32, from the cartridge detector 30, etc.) and to send coordinated control signals to one or more electronic components of the system 10.

[0077] The controller 32 may be configured to or may facilitate identification of components of a fluid and / or the state of a target region in contact with the reactant array 18 based on measured (e.g., sensed and / or calculated) levels (e.g., interferograms, images, reflectance, etc.) or changes in light sensed or collected from the reactant array 18 using the light or image sensor 28. In some examples, the controller 32 may be configured to identify components of a fluid and / or the state of a target region in contact with the reactant array 18 based on one or more of the timing of the light levels from the reactant array 18 and the absolute change in the light levels from the reactant array 18 between or before the time when the sample portion 26 of the specimen 16 is inserted or exposed to the compartment 20 of the cartridge 12 and a predetermined time after the sample portion 26 is initially inserted into the compartment 20, and the light levels from the reactant array 18 relative to predetermined or expected light levels from the reactant array 18. The controller 32 may be configured to identify components of the fluid in contact with the reactant array 18, and therefore components of the sample in the sample portion 26 of the specimen 16, and / or conditions at the location where the sample was taken (e.g., a wound, pollen from a flower, an infection, breath exhaled from a subject, sweat glands, etc.), based on light from the reactant array 18 received by the light or image sensor 28 in one or more additional or alternative ways.

[0078] The controller 32 and / or other components of the system 10 may be or include one or more computing devices that include or are coupled to one or more user interfaces. FIG. 2 shows a schematic diagram of an exemplary computing device 38 and user interface 40, where the computing device 38 and / or user interface 40 may be housed completely or partially within one or more housings 42 (e.g., housings that may or may not house other components of the system 10). The housing 42 may be an optional component, as represented by the dashed line defining the housing 42 shown in FIG. 2. Although various components are shown as being included in the computing device 38 and user interface 40, one or more of the shown components may be omitted and / or one or more additional or alternative components may be utilized.

[0079] The computing device 38 may be any suitable computing device configured to process data of or for the system 10 and may be configured to facilitate the operation of the system 10. The computing device 38 may be configured to control the operation of the system 10, in some cases, by establishing and / or outputting control signals to the light or image sensor 28 and / or other electronic components of the system 10 to interact with the reactant array 18, perform tests on fluid in the sample portion 26 of the specimen 16, and / or monitor the results of the tests. In some examples, the computing device 38 may be part of the controller 32 and may communicate with other components via a wired or wireless connection, although other suitable configurations are contemplated. If the computing device 38, or at least a portion of the computing device 38, is a component separate from the structure of the controller 32, the computing device 38 may communicate with the electronic components of the system 10 via one or more wired or wireless connections or a network (e.g., a LAN and / or a WAN). In some cases, the computing device 38 may communicate with a remote server or other suitable computing device.

[0080] An exemplary computing device 38 may include, among other suitable components, one or more processors 44, memory 46, and / or one or more input / output (I / O) units 48. Examples of other suitable components of computing device 38 not specifically shown in FIG. 2 may include, but are not limited to, communication components, a touchscreen, selectable buttons, and / or other suitable components of a computing device. As discussed, one or more components of computing device 38 may be separate from and / or incorporated into components of controller 32.

[0081] The processor 44 of the computing device 38 may include a single processor or two or more processors operating individually or in conjunction with one another. The processor 44 may be configured to receive and execute instructions, including instructions that may be loaded into the memory 46 and / or other suitable memory. Example components of the processor 44 may include, but are not limited to, a central processing unit, a microprocessor, a microcontroller, a multi-core processor, a graphical processing unit, a digital signal processor, an application specific integrated circuit (ASIC), an artificial intelligence accelerator, a field programmable gate array (FPGA), a discrete circuit, and / or other suitable types of data processing devices.

[0082] The memory 46 of the computing device 38 may include a single memory component or two or more memory components that operate independently or in conjunction with one another. Exemplary types of memory 46 may include random access memory (RAM), EEPROM, flash, suitable volatile storage, suitable non-volatile storage, persistent memory (e.g., read-only memory (ROM), hard drive, flash memory, optical disk memory, and / or other suitable persistent memory), and / or other suitable types of memory. The memory 46 may be or include a transient or non-transitory computer-readable medium. The memory 46 may include instructions stored in a transient and / or non-transitory state on a computer-readable medium, which may be executed by the processor 44 to cause the processor 44 to perform one or more of the methods and / or techniques described herein. Additionally, in some cases, the memory 46 and / or other suitable memory may store data received from the light or image sensor 28 and / or from other components of or in communication with the system 10.

[0083] I / O unit 48 of computing device 38 may include a single I / O component or two or more I / O components that operate individually or in conjunction with one another. An exemplary I / O unit 48 may be or include any suitable type of communications hardware and / or software, including, but not limited to, communications components or ports configured to communicate with electronic components of system 10 and / or with other suitable computing devices or systems. Exemplary types of I / O units 48 may include wired communication components (e.g., HDMI® components, Ethernet® components, VGA components, serial communication components, parallel communication components, component video ports, S-Video components, composite audio / video components, DVI components, USB components, optical communication components, and / or other suitable wired communication components), wireless communication components (e.g., radio frequency (RF) components, low energy BLUETOOTH® protocol components, BLUETOOTH protocol components, near field communication (NFC) protocol components, WI-FI protocol components, optical communication components, ZIGBEE® protocol components, and / or other suitable wireless communication components), and / or other suitable I / O units 48.

[0084] The user interface 40 may be configured to communicate with the computing device 38 via one or more wired or wireless connections. The user interface 40 may include, among other components, one or more display devices 50, one or more input devices 52, one or more output devices 54, and / or one or more other suitable features. Although not shown, the user interface 40 may include one or more indicators (e.g., light-emitting diodes (LEDs), LED linear arrays, numbers, etc.). In some examples, the user interface 40 may be part of or include the computing device 38. Alternatively or additionally, the user interface 40 may be part of a mobile device or a remote computing system.

[0085] Display 50 may be any suitable display. Example suitable displays include, but are not limited to, a touchscreen display, a non-touchscreen display, a liquid crystal display (LCD) screen, an LED display, a head-mounted display, a virtual reality display, an augmented reality display, a mobile device display, and / or other suitable display types.

[0086] The input device 52 may be and / or include any suitable components and / or features for receiving user input via the user interface 40. Exemplary input devices 52 may include, but are not limited to, a touchscreen, a keypad, a mouse, a touchpad, a microphone, a selectable button, a selectable knob, an optical input, a camera, a gesture sensor, an eye tracker, a voice recognition control (e.g., a microphone coupled to appropriate natural language processing components), and / or other suitable input devices. In one example, the input device 52 may include a touchscreen that allows for setting settings, initiating a fluid or target area analysis test, adjusting between screens (e.g., a test screen, a data analysis screen, a results screen, etc.), and / or taking one or more other suitable actions.

[0087] Output device(s) 54 may be and / or include any suitable components and / or features for providing information and / or data to a user and / or other computing components. Exemplary output devices 54 include, but are not limited to, a display, a speaker, a vibration system, a haptic feedback system, an optical output, and / or other suitable output devices.

[0088] Figure 3 schematically illustrates an exemplary configuration of system 10 configured to be held in a user's hand 56. While system 10 can assume a variety of different handheld (and / or non-handheld) configurations, the system 10 shown in Figure 3 can include a cartridge 12 inserted into a reading device 14 through an access opening 57. Cartridge 12 contains a specimen 16 inserted through an access opening 62.

[0089] In some configurations, the specimen 16 may include a stop 63 that may be configured to abut a portion of the cartridge 12 that defines the access opening 62 and limit insertion movement of the specimen 16. The stop 63 may be configured along the specimen 16 to position the sample portion 26 of the specimen 16 at a desired location within the cartridge 12 (e.g., to prevent the sample portion 26 from engaging an interior wall of the cartridge 12). Additionally, the specimen 16 may include perforations or other suitable configurations adjacent the stop 63 that may facilitate fracturing of the specimen at or adjacent the stop. Other suitable configurations are contemplated.

[0090] The user interface 40 of the reading device 14 shown in FIG. 3 may include a display 50 and one or more buttons 60. The user interface 40 may include additional and / or alternative components or features, including, but not limited to, one or more indicators (e.g., LEDs, linear arrays of LEDs, numbers, etc.) configured to indicate (e.g., as an alert, etc.) the results of a test, that a test has begun, that a test has completed, that a user should take action, that an action has been completed, and / or other suitable indications. Additionally or alternatively, the user interface 40 may be on or part of a remote computing device, such as a mobile device, a control station, a web page, a mobile application, and / or other suitable remote computing device. In some examples, the user interface 40 may be omitted entirely from the reading device 14, or one or more components of the user interface 40 discussed herein may be omitted from the reading device 14.

[0091] The display 50 (e.g., a touchscreen display or a non-touchscreen display) may show an image 64 captured by the reading device 14 (e.g., captured by the light or image sensor 28). The image 64 may be a live image and / or a previously captured photograph or image. As shown schematically in FIG. 3, the image 64 may be a live image of a CSA 66 including a reactant array 18. Additionally, the display 50 may display material other than the image 64, including, but not limited to, instructions for testing the fluid, test status (e.g., the progression of steps in the analysis of the reactant array 18), system status, results of the analysis of the reactant array 18, marketing indicia, branding indicia, video, user pictures, artwork, etc.

[0092] One or more buttons 60 may be selected by a user to cause the reading device 14 and / or cartridge 12 to perform one or more actions. For example, a user may interact with one or more buttons 60 to start the pumps of the reading device 14 and / or cartridge 12, power the reading device 14 on and / or off, start the motor of the reading device 14, start analysis of the reactant array 18, start the light or image sensor 28 to take an image or capture light, eject the cartridge 12 and / or sample 16, mark the cartridge 12 as used, start the display 50, and / or cause the reading device 14 and / or cartridge 12 to perform one or more other suitable operations.

[0093] 4-6 schematically illustrate exemplary configurations of cartridge 12 including a housing 68 having an access opening 58 and a transparent portion 70 (e.g., a window formed from glass, polymer, and / or other suitable transparent material, etc.) through which a reading device 14 can view, collect light, and / or image a reactant array 18 disposed within a compartment 20. In some examples, housing 68 can be formed from a single housing component or structure with access opening 58 being the only access point to compartment 20 in which reactant array 18 and / or specimen 16 may be located, although other suitable configurations are contemplated. Although not required, cartridge 12 can include a door 72 configured to adjust in the direction of arrow A or other suitable direction between an open position in which access opening 58 may be accessible and a closed position in which access opening 58 is inaccessible or blocked. In some configurations, door 72 can be configured to fluidly seal (e.g., hermetically seal) access opening 58 and / or compartment 20 when in the closed position.

[0094] In addition to or instead of utilizing a door to fluidly seal (e.g., hermetically seal) the compartment 20 from the exterior of the housing 68, one or more valves 76 may be disposed at or within the access opening 58. In some examples, as shown in FIG. 4 , a single valve 76 (e.g., a check valve and / or other suitable type of valve) may be located at the access opening 58, and the single valve 76 may include a slit 78 or other opening that is biased closed and may open upon engagement with the specimen 16. When the specimen 16 extends through the valve 76, the valve 76 may be configured to seal around the specimen 16. When the specimen 16 is to be fully disposed within the compartment 20, the valve 76 may be configured to reseal the access opening 58 after the specimen 16 is inserted through the access opening 58. To prevent the valve 76 from engaging the sample portion of the specimen 16, the specimen 16 may include a distal blocker configured to engage the valve and open the valve 76, preventing the valve 76 from engaging the sample portion of the specimen 16, and / or the valve 76 may be configured to open or be opened without the specimen 16 engaging the valve 76.

[0095] Instead of or in addition to utilizing one or more valves 76, one or more seals (e.g., single-use seals such as foil seals, rupturable membranes, and / or other suitable seals) may be utilized at or adjacent to the access opening 58 to seal the compartment 20 from the ambient environment and mitigate contamination of the reactant array 18. In some examples, the single-use seal may extend across the access opening 58 and may be punctured or broken to remove the seal from the access opening 58. In some examples, the single-use seal may be a peel seal configured to be peeled from the access opening 58 prior to inserting the specimen 16 through the access opening 58.

[0096] 4, the housing 68 may be formed from a single housing component. However, while the door 72 may be considered part of the housing 68, this is not required. In some examples, the door 72 may be a first component of the housing 68, and the portion of the housing 68 that defines the compartment 20 may be a second component of the housing 68.

[0097] The housing 68 may include or define one or more compartments 20. As shown in Figures 4-6, the housing 68 may have a first compartment 20a for receiving a sample portion 26 of the specimen 16 and a second compartment 20b for containing a reactant array 18 (which may be part of the CSA 66, for example). When two or more compartments 20 are utilized within the housing 68, the compartments 20 may be fluidly connected by one or more fluid passages 74 such that fluid may travel from one compartment 20 (e.g., the first compartment 20a) to another compartment (e.g., the second compartment 20b).

[0098] 4 shows a schematic perspective view of cartridge 12 with door 72 adjusted to an open position to provide access to access opening 58. Valve 76 may be in a closed position to seal compartment 20 from the exterior of housing 68.

[0099] The door 72 may be biased to a closed position to seal the access opening 58, and a user may apply a force to the door 72 to adjust the door 72 to an open position against the bias. In some examples, the door 72 may be adjusted to an open position in response to a user engaging the door 72 with a specimen 16. In some configurations, the door 72 is automated and may be opened and / or closed in response to a control signal received from the reading device 14 and / or in response to the specimen detector 24 or cartridge detector 30 detecting that a specimen 16 is in proximity to and / or disposed within the cartridge 12. In some configurations, the door 72 may not be biased in any position or direction.

[0100] Figure 5 shows a perspective view of the configuration of cartridge 12 shown in Figure 4, with door 72 in an open position and specimen 16 inserted into access opening 58 and into first compartment 20a through valve 76 and slit 78 (e.g., sample portion 26 of specimen 16 is at least partially inserted into first compartment 20a). As shown in Figure 5, valve 76 may seal around specimen 16 as it is inserted through slit 78 and / or as it advances through valve 76, although other configurations are contemplated.

[0101] The specimen 16 may be any suitable type of specimen configured to extend into the first compartment 20a through the access opening 58. As shown in Figure 5, the specimen 16 may be a test strip, although other suitable specimens 16 may be utilized, including, but not limited to, a swab, a stick-on swab (e.g., a Q-tip), and / or other suitable specimens.

[0102] 6 schematically illustrates a perspective view of the cartridge 12 configuration shown in FIG. 4 with the door 72 in a closed position and the specimen 16 fully inserted into the first compartment 20a. Once at least the sample portion 26 of the specimen 16 is inserted (e.g., fully inserted) into the first compartment 20a, fluid may flow from the sample on the sample portion 26 through the fluid passageway 74 to or onto the reactant array 18 of the CSA 66, such that, if an analyte of interest is detected, the reactants 67 of the reactant array 18 may react with the fluid. In some configurations, the fluid in the compartment 20 may be agitated to facilitate movement of fluid from the sample on the sample portion 26 to the reactant array 18 by moving the cartridge 12 and / or the specimen 16 (e.g., the sample portion 26), by pumping the fluid in the cartridge 12 with a pump (not shown), and / or by agitating the fluid in one or more other suitable manners.

[0103] In some examples, the door 72 may be part of a lock (e.g., the lock 22 and / or other suitable lock) for the cartridge 12. For example, once the door 72 is moved from the open position to the closed position, the door 72 may be permanently placed in the closed position, preventing the cartridge 12 from being reused with additional specimens 16.

[0104] In some examples, the door 72 may include a blade surface configured to engage the specimen 16 and separate the specimen 16 into two or more portions (e.g., a non-specimen portion and a sample portion 26). For example, the top surface of the door 72 may be a blade surface configured to engage the specimen 16 when the specimen 16 extends out of the access opening 58 when the door 72 is adjusted from the open position to the closed position such that the specimen 16 is separated into two portions.

[0105] 7-9 schematically illustrate an exemplary configuration of the cartridge 12, including a housing 68 having a first component 68a (e.g., a base) and a second component 68b (a lid or cover), an access opening 58, and a transparent portion 70 (e.g., a window formed from glass, polymer, and / or other suitable transparent material) through which the reading device 14 can view, collect light, and / or image the reactant array 18 disposed in the compartment 20. The first component 68a of the housing 68 may completely or at least partially define the compartment 20, within which the CSA 66 having the reactant array 18 is located, and within which the specimen 16 may be disposed when inserted into the housing 68. The second component 68b of the housing 68 may include the transparent portion 70 and a first connector 80 for coupling to a second connector 84 on the first component 68a of the housing 68. Although not required, the first connector 80 may include a blade surface 82, which may be sharp or blunt, and may be configured to engage and detach the specimen 16 extending from the cartridge 12.

[0106] The first and second components 68a, 68b of the housing 68 may be adjustable in the direction of arrow B or other suitable direction between an open position, in which the access opening 58 may be accessible, and a closed position, in which the access opening 58 is inaccessible or blocked. In some configurations, the first and second components 68a, 68b may be configured to fluidly seal (e.g., hermetically seal) the access opening 58 and / or the compartment 20 when in the closed position. Although not shown, one or both of the first and second components 68a, 68b of the housing 68 may include one or more seals configured to engage other components of the housing 68 to fluidly seal the access opening 58 and / or the compartment 20.

[0107] The housing 68 may include or define one or more compartments 20. As shown in Figures 7-9, the housing 68 may have a single compartment 20 for receiving a sample portion 26 of the specimen 16 and for receiving a reactant array 18 (e.g., a reactant array 18 of a CSA 66 or other suitable reactant array 18). Alternatively, the housing 68 may have multiple compartments 20 for receiving sample portions 26 of the specimen 16 containing a reactant array 18, and / or for receiving or containing one or more other components of the cartridge 12.

[0108] The first component 68a may define a guide 86 configured to receive a portion of the specimen 16. In some examples, when the specimen 16 is received within the guide 86, the specimen 16 may be aligned at a desired location within the compartment 20 relative to the reactant array 18. In some examples, when the specimen 16 is received within the guide 86, the specimen 16 may be aligned with the first connector 80 and the second connector 84 such that the specimen 16 may be detached at a desired location when the first component 68a and the second component 68b are adjusted to a closed position, the blade surface 82 engages the specimen 16, and the first connector 80 and the second connector 84 are coupled to one another.

[0109] The first connector 80 and the second connector 84 may be part of a lock (e.g., lock 22 and / or other suitable lock) of the cartridge 12. For example, once the first and second components 68a, 68b are adjusted to the closed position, a latch or other feature of the first connector 80 may engage a feature of the second connector 84 to permanently maintain the first and second components 68a, 68b of the housing 68 in the closed position, preventing the cartridge 12 from being reused with additional specimens 16.

[0110] 7 schematically illustrates a perspective view of cartridge 12 with first and second components 68a, 68b of housing 68 adjusted to an open position to provide access to access opening 58 (e.g., for placing a specimen in compartment 20, removing used material from compartment 20, cleaning compartment 20, etc.). Although not required, first and second components 68a, 68b may be coupled to one another via a hinge and may pivot relative to one another.

[0111] 8 schematically illustrates a perspective view of the configuration of cartridge 12 shown in FIG. 7 with first component 68a and second component 68b in the open position and specimen 16 inserted into access opening 58 such that sample portion 26 of specimen 16 is inserted into compartment 20 at a desired location proximate (e.g., in fluid communication with) reactant array 18. As shown in FIG. 8, non-sample portion 34 of specimen 16 can be positioned in guide 86 to facilitate positioning sample portion 26 within compartment 20 and aligning non-sample portion 34 with blade surface 82.

[0112] The specimen 16 may be any suitable type of specimen configured to extend into the compartment 20 through the access opening 58. As shown in Figure 8, the specimen 16 may be a stick-on swab (e.g., a Q-tip) and / or one or more other suitable specimens.

[0113] 9 schematically illustrates a perspective view of the cartridge 12 configuration shown in FIG. 7 with first component 68a and second component 68b in a closed position, sample portion 26 of specimen 16 within compartment 20 (not shown), and detached non-sample portion 34 external to and separated from cartridge 12. Once sample portion 26 of specimen 16 is inserted and enclosed within compartment 20, fluid may flow from the sample on sample portion 26 to or onto reactant array 18 of CSA 66, such that reactants 67 of reactant array 18 may react with the fluid if an analyte of interest is detected. In some configurations, fluid in compartment 20 may be agitated to promote movement of fluid from the sample on sample portion 26 to reactant array 18 by moving cartridge 12, pumping fluid within cartridge 12 with a pump (not shown), and / or agitating the fluid in one or more other suitable manners.

[0114] 10 and 11 schematically illustrate an exemplary configuration of a cartridge 12 including a housing 68 having a first component 68a (e.g., a base) and a second component 68b (a lid or cover), an access opening 58, and a transparent portion 70 (e.g., a window formed from glass, polymer, and / or other suitable transparent material) through which a reading device 14 can view, collect light, and / or image a reactant array 18 disposed in a compartment 20. The first component 68a of the housing 68 may completely or at least partially define a compartment 20, within which a CSA 66 having a reactant array 18 may be located, and upon insertion of a specimen 16 into the housing 68, the specimen 16 may be disposed in the compartment 20. The second component 68b of the housing 68 may include a transparent portion 70 and a first connector 80 (e.g., a peg or leg) for coupling to a second connector 84 (e.g., a hole or opening) on ​​the first component 68a of the housing 68.

[0115] The first and second components 68a, 68b of the housing 68 may be adjustable in the direction of arrow C or other suitable direction between an open position, in which the access opening 58 may be accessible, and a closed position, in which the access opening 58 is inaccessible or blocked. In some configurations, the first and second components 68a, 68b may be configured to fluidly seal (e.g., hermetically seal) the access opening 58 and / or the compartment 20 when in the closed position. Although not shown, one or both of the first and second components 68a, 68b of the housing 68 may include one or more seals configured to engage other components of the housing 68 to fluidly seal the access opening 58 and / or the compartment 20, respectively.

[0116] The housing 68 may include or define one or more compartments 20. As shown in Figures 9 and 10, a first component 68a of the housing 68 may have a first compartment 20a for receiving a sample portion 26 of the specimen 16 and a second compartment 20b for containing a reactant array 18 (e.g., a reactant array 18 of a CSA 66 or other suitable reactant array 18). When two or more compartments 20 are utilized within the housing 68, the compartments 20 may be fluidly connected by one or more fluid passageways 74 such that fluid may move from one compartment 20 (e.g., the first compartment 20a) to another compartment (e.g., the second compartment 20b).

[0117] The first component 68a of the housing 68 may define a guide 86 configured to receive a portion of the specimen 16. In some examples, when the specimen 16 is received in the guide 86, the specimen 16 may be aligned at a desired position in the first compartment 20a relative to the reactant array 18 and the fluid passage 74 in the second compartment 20b.

[0118] The second component 68b of the housing 68 may include a resilient seal 88 aligned with the guide 86. When the first component 68a and the second component 68b of the housing 68 are in the closed position and the specimen 16 (e.g., the non-sample portion 34 of the specimen 16) is within the guide 86, the resilient seal 88 may extend around the specimen 16 and conform to the shape of the specimen 16 to form a fluid-tight seal when the housing 68 is in the closed configuration.

[0119] In some examples, the first connector 80 and the second connector 84 may be part of a lock (e.g., lock 22 and / or other suitable lock) of the cartridge 12. For example, when the first and second components 68a, 68b of the housing 68 are adjusted to the closed position, the first connector 80 may engage features of the second connector 84 (e.g., via a friction fit, a snap, a latch, etc.) to permanently maintain the first and second components 68a, 68b of the housing 68 in the closed position and prevent the cartridge 12 from being reused with additional specimens 16.

[0120] 10 schematically illustrates a perspective view of cartridge 12 with first component 68a and second component 68b adjusted to an open position to provide access to access opening 58, and with specimen 16 inserted into access opening 58, such that sample portion 26 of specimen 16 is present in first compartment 20a at a desired location adjacent to (e.g., in fluid communication with) reactant array 18 and / or fluid passage 74. As shown in FIG. 10 , non-sample portion 34 of specimen 16 can be positioned within guide 86 to facilitate placement of sample portion 26 within first compartment 20a and aligning non-sample portion 34 with elastic seal 88.

[0121] The specimen 16 may be any suitable type of specimen configured to extend into the compartment 20 through the access opening 58. As shown in Figure 10, the specimen 16 may be a stick-on swab (e.g., a Q-tip) and / or one or more other suitable specimens.

[0122] 11 schematically illustrates a perspective view of the configuration of cartridge 12 shown in FIG. 10 with first component 68a and second component 68b in a closed position, sample portion 26 of specimen 16 in first compartment 20a (not shown), and non-sample portion 34 extending from guide 86 and external to cartridge 12. Resilient seal 88 extends into or around guide 86 to engage specimen 16, fluidically seal and maintain the position of specimen 16 relative to cartridge 12. When sample portion 26 of specimen 16 is inserted and enclosed within first compartment 20a, fluid may flow from the sample on sample portion 26, through fluid passage 74, and onto or at reactant array 18 of CSA 66 in second compartment 20b, such that reactants 67 of reactant array 18 may react with the fluid if an analyte of interest is detected. In some configurations, the fluid in the first compartment 20a, the fluid passage 74, and / or the second compartment 20b may be agitated by moving the cartridge 12, by pumping the fluid in the cartridge 12 with a pump (not shown), and / or by agitating the fluid in one or more other suitable manners, thereby promoting the movement of fluid from the sample on the sample portion 26 to the reactant array 18.

[0123] 12 and 13 schematically illustrate exemplary configurations of cartridge 12 including a housing 68 having a first component 68a (e.g., a base) and a second component 68b (a lid or cover), an access opening 58, and a transparent portion 70 (e.g., all or at least a portion of second component 68b of housing 68 formed from glass, polymer, and / or other suitable transparent material) through which reading device 14 can view, illuminate, collect light from, and / or image reactant array 18 disposed within compartment 20. First component 68a of housing 68 can completely or at least partially define compartment 20, and when CSA 66 having reactant array 18 is positioned within compartment 20 and specimen 16 is in fluid communication with compartment 20, fluid from specimen 16 can move within compartment 20.

[0124] The second component 68b of the housing 68 can be releasably or permanently coupled to the first component 68a of the housing 68. When the first component 68a and the second component 68b are coupled to one another, the seal between the components 68a, 68b can be a hermetic seal.

[0125] The first component 68a of the housing 68 may include one or more cartridge ports 90 (e.g., two cartridge ports 90 as shown in FIG. 12 , or any other suitable number of cartridge ports 90) configured to engage the specimen 16. In operation, the cartridge ports 90 may be configured to couple to tubing and / or specimen 16, which may be a container containing a sample, which may be configured to couple to the cartridge ports 90.

[0126] The second component 68b may include a first portion 68b' that may cover or function as a lid for the first component 68a of the housing 68, and a second portion 68b'' configured to engage and optionally function as a cover for a specimen 16 coupled to the first component 68a of the housing 68. The second portion 68b'' of the second component 68b may extend from and pivot relative to the first portion 68b' via a living hinge 94 or other suitable hinge. In some configurations, the second portion 68b'' may include a latch 92 or other feature configured to engage the specimen 16 when the specimen 16 is coupled to the cartridge port 90.

[0127] One or more valves 76 may be disposed at or within the access openings 58 extending through the cartridge ports 90. In some examples, as shown in FIG. 12 , a single valve 76 (e.g., a check valve and / or other suitable type of valve) may be located at the access opening 58 of each cartridge port 90, and the single valve 76 may include a slit 78 or other opening that is biased closed and may open upon engagement with a specimen 16. If the specimen port of the specimen 16 extends through the valve 76, the valve 76 may be configured to seal around the specimen port. Alternatively or additionally, the cartridge ports 90 may be covered with a peelable or pierceable seal.

[0128] The first portion 68b' of the second component 68b of the housing 68 and the first component 68a may be fixedly sealed to one another, although this is not required; the first component 68a and the second component 68b of the housing 68 may be adjustable relative to one another to provide access to the compartment 20. When the first component 68a and the second component 68b are sealed to one another, the seal may be a fluid-tight (e.g., air-tight) seal.

[0129] 12 schematically illustrates a perspective view of cartridge 12 with second portion 68b'' of second component 68b adjusted to an open position to receive specimen 16 and provide access to access opening 58. In the open position, second portion 68b'' can be rotated upward to facilitate engagement of specimen 16 with cartridge port 90. Alternatively, cartridge 12 may contain specimen 16 (e.g., in a container or in a carrier configuration), and second portion 68b'' disposed in the open position may facilitate receipt of sample 96 within specimen 16.

[0130] 13 schematically illustrates a cross-sectional view of the cartridge 12 configuration shown in FIG. 12 with the specimen 16 (e.g., in a container configuration) engaged with the cartridge port 90 of the first component 68a of the housing 68. While the specimen 16 is shown as connectable to and a separate component from the housing 68, as discussed, the specimen 16 may be part of the housing 68 and / or may be a permanent structure of the housing 68.

[0131] The specimen 16 may include one or more specimen ports 98 configured to engage and / or extend through the cartridge ports 90, as shown in FIG. 13. In some examples, the specimen ports 98 may be configured to extend through a valve 76 in the access opening 58, which may seal around the specimen ports 98.

[0132] Before, during, or after the specimen 16 is coupled to the cartridge port 90, the second portion 68b'' of the second component 68b may be adjusted and coupled to the specimen 16. In some examples, the second portion 68b'' may be coupled to the specimen 16 via a snap connection (e.g., a permanent connection or a reversible connection) between the latch 92 and a notch 99 in the specimen 16. Although not required, the second portion 68b'' coupled to the specimen 16 may function as a cover to the specimen 16 such that fluid from the sample 96 in the specimen 16 can only exit the specimen 16 through the specimen port 98.

[0133] Once the specimen 16 is securely coupled to the cartridge 12 and in fluid communication with the compartment 20, fluid may flow from the sample 96 within the specimen 16, through the specimen port 98, through the cartridge port 90, and onto or at the reactant array 18 of the CSA 66 in the second compartment 20b, such that reactants 67 of the reactant array 18 may react with the fluid if an analyte of interest is detected. In some configurations, the fluid within the compartment 20 and / or specimen 16 may be agitated to facilitate movement of fluid from the sample 96 to the reactant array 18 by moving the cartridge 12, pumping the fluid within the cartridge 12 with a pump (not shown), and / or agitating the fluid in one or more other suitable manners.

[0134] FIG. 14 schematically illustrates an exemplary method 100 that may facilitate analysis of a reactant array (e.g., a reactant array of a CSA, or other suitable reactant array) exposed to fluid from a sample (e.g., as part of a fluid analytical test for one or more fluids of interest). The method 100 may include inserting 102 a cartridge into a device (e.g., a reading device) configured to analyze the reactant array. In some configurations, the cartridge may include a CSA including a reactant array configured to be exposed to fluid and an opening configured to receive and / or engage a specimen having a sample thereon. The device may be configured to collect light from the reactant array through the cartridge, analyze the collected light instantaneously, and / or analyze changes in the collected light over time.

[0135] Further, the method 100 may include inserting 104 a specimen into the cartridge. In some cases, the specimen may be disposed within a compartment of the cartridge or may be in fluid communication with a compartment of the cartridge, which may be in fluid communication with a reactant array of the CSA. In some examples, the specimen may include a sample portion having a sample thereon, from which fluid may ooze or be released onto the reactant array. If included, the sample portion of the specimen may be disposed within the compartment of the cartridge when the specimen is inserted into the cartridge and / or at one or more other suitable times. A sample may be collected from an area of ​​interest (e.g., a wound, pollen from a flower, an infection, breath exhaled from a subject, sweat glands, etc.) by applying the specimen to the area of ​​interest.

[0136] In some configurations, once a sample is inserted into the cartridge and secured within the cartridge, the sample may be locked within the cartridge. Thus, the cartridge may be prevented from being used a second time with one or more other samples. In some examples, a reading device that accepts the cartridge may be able to detect whether the cartridge and / or sample have been previously used, as discussed herein or elsewhere, and if the cartridge and / or sample are determined to have been used, the reading device may refuse to perform a fluid analysis test that uses the sample and / or cartridge.

[0137] Although not required, light from one or more light sources may be applied to the reactants of the reactant array. The light may be applied directly to the reactants of the reactant array and / or through a transparent portion of the substrate. Applying light to the reactants of the reactant array as they are exposed to the fluid may facilitate collection of light from the reactant array.

[0138] The method 100 may include collecting 106 light from the reactant array of the CSA. The light from the reactant array may be collected by a reading device using a light sensor or an image sensor. Although not required, the light may be collected from the reactant array while the light is irradiating the reactant array.

[0139] In some configurations, the reading device may be configured to analyze the level of wavelengths of light collected from the reactant array. The level of wavelengths of light collected from the reactant array may be measured in any suitable manner, including, but not limited to, counting photons at one or more wavelengths of collected light, measuring the amount of light collected at one or more wavelengths of collected light, the change in photon counts over time for one or more wavelengths of collected light, the change in pixel values ​​of the image sensor over time (e.g., the change in pixel grayscale values), and / or the level of wavelengths of collected light may be measured in one or more other suitable manners.

[0140] Measurements of the levels of wavelengths of light collected from a reactant array can be used to identify analytes (e.g., components) of a fluid to which the reactant array may be exposed. In some examples, if the levels of wavelengths of light collected over time match or are substantially similar to a set of expected wavelength levels of a reactant exposed to a known analyte (e.g., a fluid, or a component of a fluid), the known analyte may be identified as being present in the fluid tested in a fluid analytical test. Exemplary techniques for measuring the levels of wavelengths of light collected from a reactant array and comparing the measurements to known measurements associated with a fluid are discussed in PCT / US2023 / 083024 (Attorney Docket No. 1519.1004111), entitled "DEVICES, METHODS, AND SYSTEM FOR MEASURING AND RECORDING SPECTRUM OF A REACTANT ARRAY," having the same filing date as this specification, and which is incorporated herein by reference in its entirety for all purposes.

[0141] Although the subject matter has been described in language specific to structural features and / or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.

[0142] Unless expressly indicated otherwise, no method or technique described herein should be construed as requiring that its steps be performed in a particular order. This applies to any anticipated non-expressive basis for interpretation, including logical considerations regarding the arrangement or operational flow of steps, simple meaning derived from grammatical construction or punctuation, and the number or type of embodiments described herein.

[0143] It should be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, using any of the features of one exemplary embodiment in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. A system for analyzing a reactant array, comprising: a cartridge including a reactant array, a compartment for receiving a specimen in fluid communication with the reactant array, and an access opening configured to receive a sample portion of the specimen; and a device for analyzing the reactant array when the cartridge is received in the device; A system comprising:

2. 2. The system of claim 1, wherein the cartridge comprises a housing at least partially enclosing the reactant array, the housing defining the compartment for receiving the sample and the access opening through which the sample is inserted into the compartment.

3. 3. The system of claim 2, wherein the housing comprises first and second components adjustable relative to one another between an open position defining the access opening and a closed position blocking the access opening.

4. The system of any one of claims 1 to 3, wherein the housing is formed from a single housing component.

5. The system of any one of claims 1 to 4, wherein the cartridge includes a lock having a locked position to prevent removal of the specimen from the cartridge.

6. The system of claim 5 , wherein the lock is automatically adjusted from an unlocked position to the locked position in response to the insertion of the specimen into the cartridge.

7. The system of any one of claims 1 to 6, wherein the device is configured to automatically detect insertion of the cartridge into the device.

8. The system of any one of claims 1 to 7, wherein the device is configured to automatically detect the insertion of the specimen into the cartridge.

9. The system of any one of claims 1 to 8, wherein the device is configured to collect light from the reactant array in response to the cartridge being placed in the device.

10. 10. The system of claim 1, further comprising the specimen, the specimen including the sample portion for placement within the compartment and a non-sample portion extending out of the compartment.

11. The system of claim 10 , wherein the cartridge is configured to separate a portion of the non-sample portion from the sample portion.

12. 1. A cartridge for use with a device for analyzing a reactant array, comprising: a reactant array; a housing at least partially enclosing the reactant array, the housing defining a compartment for receiving a sample; an access opening extending from an exterior of the housing into the compartment for receiving the specimen; A cartridge comprising:

13. The cartridge of claim 12 , wherein the housing comprises first and second components adjustable relative to one another between an open position defining the access opening and a closed position blocking the access opening.

14. 14. A cartridge according to claim 12 or 13, wherein the access opening is a through hole extending from an outer surface of the housing to the compartment for receiving the specimen.

15. The cartridge of claim 14 , wherein the through-hole is configured to receive the specimen, the specimen comprising a swab.

16. The cartridge of any one of claims 12 to 15, further comprising a lock configured to prevent removal of the specimen from the housing.

17. 17. The cartridge of claim 16, wherein the lock is configured to transition from an unlocked position to a locked position in response to receiving the specimen in the compartment.

18. The cartridge of any one of claims 12 to 17, further comprising a blade configured to sever the specimen received in the compartment.

19. The cartridge of any one of claims 12 to 18, wherein the cartridge is configured to fluidly isolate the compartments and the reactant array from fluids external to the housing.

20. 1. A method for analyzing a reactant array, comprising: inserting a cartridge into a device, the cartridge including a compartment and a reactant array, the device configured to analyze the reactant array by collecting light through the cartridge; inserting a specimen into the cartridge, the specimen including a sample portion, the compartment in fluid communication with the reactant array, the sample portion disposed within the compartment of the cartridge; collecting light from the reactant array using the device after the cartridge is inserted into the device; A method comprising:

21. 21. The method of claim 20, further comprising locking the specimen within the cartridge in response to receiving the specimen within the cartridge.

Images